Computerized Systems


VTI computer validation engineers will help ensure that your computerized systems are developed and qualified following a structured life cycle approach consistent with the Good Automated Manufacturing Practice (GAMP5) guidance.

A Proven Process that Benefits You

We have developed a process and a suite of services designed to ensure that you are in compliance with the applicable sections of the cGMP/GLP/GCP, 21 CFR Part 11, Annex 11 and Health Canada. This process will assure the quality of computerized systems through the development and/or execution of requirements, specifications, design, coding, testing, installation and acceptance. This process includes the following steps customized to your unique needs:

  • Excel Spreadsheet Validation
  • ERP, QMS, LIMS and other GXP software Program Validation
  • Supplier/Vendor Audits
  • Client Validation Life Cycle Audit
  • 21 CFR Part 11 Audits/ Remediation Plans
  • Policies & Procedures Development
  • Software Validation
  • Validation Plans
  • IT Network Qualification
  • Disaster Recovery Plans
  • Operation & Security SOPs
  • Change Management and Control
  • System User Requirements and Design Documents
  • Protocols, Test Plans, Test Scripts
  • 21 CFR Part 11 Training
  • Data Integrity, Data Classification and Data Control Assessment and implementation